MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM; METZENBAUM GRASPING SCISSORS

Model Number	A64810A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device will not be returned to olympus for evaluation.However, a photograph of the device was provided.The jaws at the distal end appeared to be intact, however, the pull rod (ball) at the proximal end of the device was observed broken off the device.The manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Additional 510(k): k944201.
Event or Problem Description
Olympus was informed the customer hiq+, metzenbaum grasping scissors has "broken parts of the jaws".Mechanical malfunction during assembly by excessive force.The customer reported problem was found at preparation for use.No procedure involved and no injury or impact to patient or other was reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported broken jaws/mouth could not be definitively determined, however, based on the available information provided by the customer, the issue was likely the result of a device wear and incorrect handling/excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM
• Common Device Name: METZENBAUM GRASPING SCISSORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16645117
• Report Number: 9610773-2023-00913
• Device Sequence Number: 6061113
• Product Code: HET
• UDI-Device Identifier: 04042761010320
• UDI-Public: 04042761010320
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A64810A
• Device Catalogue Number: A64810A
• Device Lot Number: 19304-018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown